FDA.reportPublic FDA data

LA2-14A

Primary DI
08800290042788
Brand
LA2-14A
Company
SAMSUNG MEDISON CO., LTD.
Model
USP-L02EFFB/WR
Published
2025-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192903000RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2020-01-06IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800290042788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800290042788088002900427888800290042788

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

Regulatory Flags#

DUNS number
687785691
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
088061677611725D VIEWERUSO-U0N5B0B/WR2016-09-26
088061677894665D ViewerUSO-U0N5B0K/WR2018-05-26
08800010500840SonoSync+USO-SSPS200/SW2026-08-18
08800290029376CA2-13MUSP-C02DFSA/WW2026-08-18
08800290036169PA2-9SUSP-P029FSA/WW2026-08-18
08800290036237BCC2-13USP-B02DF1A/WW2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemV6 ONE2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemV7 ONE2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemV8 ONE2026-08-18
08800289979132cV4 Diagnostic Ultrasound SystemcV42025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemcV52025-09-03
08806167766030LA3-16ADLA3-16AD2025-09-03
08809944906476LM2-18DLM2-18D2025-09-03
08809944942450miniER7miniER72025-09-03
08800290027266PA2-9SUSP-P029NSA/WR2026-04-03
08800290027419LA2-9SDUSP-LF29NSA/WR2026-04-03
08800290028638CA2-8ADUSP-C028N7B/WW2026-04-03
08800290029390EV2-10AUSP-V02AN1B/WW2026-04-03
08800290029420CV1-8AEUSP-VN18NSC/WW2026-04-03
08800290029512LA3-16ADUSP-L03GN4B/WW2026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.IYN2026-10-26
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.ITX2026-10-26
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.IYO2026-10-26
07070554100863Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100870Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100887Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100894Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100900Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
00850018318051AI PlatformExo Imaging, Inc.IYN2026-10-22
03770033463055FETOLYDIAGNOLYIYO2026-10-22
03770033463055FETOLYDIAGNOLYIYN2026-10-22
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
06948941160022Bladder ScannerMeda Co., LtdIYO2026-10-08
00855683006821AquaflexPARKER LABORATORIES INCIYO2026-10-01
00855683006845AquaflexPARKER LABORATORIES INCIYO2026-10-01
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayQISDA CORPORATIONITX2026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.IYO2026-09-30
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30